F.D.A. Imposes Tougher Rules for Acne Drug

--------------------------------------------------------------------------------

August 13, 2005
F.D.A. Imposes Tougher Rules for Acne Drug
By GARDINER HARRIS
WASHINGTON, Aug. 12 - The Food and Drug Administration announced tough
new regulations Friday for use of the acne drug Accutane. Officials of
the agency said they hoped that the rules would reduce the hundreds of
miscarriages, birth defects and abortions associated with the drug
each year.

The regulations, which apply to generic versions of Accutane as well,
require doctors and patients to register in an electronic database
before it can be dispensed. Female patients of childbearing age must
take two pregnancy tests and use two forms of birth control to get the
drug. And doctors and pharmacists must confirm that the requirements
have been met.

The new program is the latest and by far most drastic of more than 40
efforts by the agency in the last 22 years to reduce harm from
Accutane, an oral medicine made by Roche Holding, while allowing its
continued use.

Dr. Nancy Green, medical director for the March of Dimes, cheered the
announcement.

"If this doesn't work," Dr. Green said, "we will call for the F.D.A.
to take this drug off the market."

A Roche spokeswoman, Shelley Rosenstock, said the company also
welcomed the rules.

"Roche continues to support, to the extent possible, efforts to reduce
fetal exposures" to Accutane, Ms. Rosentstock said.

Health officials say the new plan is the latest sign the F.D.A. is
losing faith that the nation's doctors and pharmacists can adequately
safeguard the health of patients. Before 1998, the agency largely
confined itself to advising physicians and pharmacists about how to
prescribe and dispense safely any drugs with potentially dangerous
adverse effects, and trusted that its advice would be followed. But
experts say that time after time over the last decade, medical
professionals have ignored the advice, providing drugs to patients at
risk of severe complications.

In some cases, the agency has asked that a drug be withdrawn because
physicians and pharmacists proved unwilling to control its use. But
such withdrawals have left stranded thousands of patients who contend
that they needed those drugs to lead normal lives.

So instead, the agency has begun fashioning restricted distribution
programs, like the one it announced on Friday, to ensure that health
professionals follow its guidelines. Among the first was a program
created in 1998 to ensure that thalidomide, infamous for causing
thousands of birth defects in European babies during the 1960's, could
be safely used as a leprosy drug. More such programs have followed,
including one for the abortion drug Mifeprex.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,
a consumer advocacy organization, said the F.D.A. was recognizing that
patients needed protection from irresponsible physicians and
pharmacists. Dr. Wolfe added that drug companies were largely to
blame, though, saying their huge marketing efforts often encouraged
doctors to prescribe drugs excessively.

But Dr. Mark Naylor, an Oklahoma dermatologist, said with regret that
many doctors would stop prescribing Accutane because of the F.D.A.'s
new restrictions. While it is unfortunate that some doctors may have
failed to follow earlier, voluntary guidelines on Accutane, Dr. Naylor
said, "it's up to physicians and patients to decide how the drug gets
used, not the F.D.A."

The drug agency approved Accutane in 1982 for patients suffering from
severe, disfiguring acne. There are about 6,000 patients with this
severe condition in the United States, most of them men. For such
patients, the drug has provided a nearly miraculous cure. By 2002, the
last year before generic versions of the medicine entered the market,
sales of Accutane in the United States had risen to $380 million, with
doctors writing 170,000 prescriptions a month, half of which went to
women.

Although animal studies had suggested that Accutane caused birth
defects, the drug agency initially imposed few restrictions on its
sale. When the first reported birth defect occurred in 1983, the
agency responded by requiring pharmacists to affix red warning
stickers to every bottle of Accutane describing its effects on
fetuses. More than 40 label or other regulatory changes followed, but
birth defects only increased. The drug, reports suggest, may also
cause some patients to become suicidal.

In 2001, Roche and the F.D.A. announced a plan to cut fetal exposures
of Accutane to zero. Patients were asked to sign a consent form
describing Accutane's risks. Doctors were asked to affix yellow
stickers to their prescriptions to verify that female patients capable
of bearing children had undergone two pregnancy tests and promised to
use two forms of birth control.

But the system was entirely voluntary, and it did nothing to reduce
the number of pregnancies among women taking the drug. Some women
never got pregnancy tests or, in a few cases, had positive pregnancy
tests and still were given it. From 2001 to 2003, the agency received
reports of 325 pregnancies among women taking it, and agency officials
say such a number is probably only a fraction of the real total,
because most miscarriages and abortions are most likely not reported
to them.

In February 2004, an advisory committee recommended that many aspects
of the program to control Accutane's risks become mandatory. With its
announcement Friday, the F.D.A. has followed that advice. The new
plan, called iPledge, is expected to become fully operational by the
end of the year. The program will apply to men as well as to women, in
part because of the reports of Accutane's psychiatric effects but also
because it seeks to bar male patients' sharing the drug with women not
eligible to receive it.

Under the program, doctors who wish to prescribe Accutane or its
generic forms must first go to a Web site, list the patient's name in
the registry and, using an identification number for the patient,
confirm in the case of women that two pregnancy tests have been
performed. Patients, using the same identification code, must either
call an 800 number or visit a Web site to receive education about the
drug's risks, and women must confirm that they are taking two forms of
birth control.

When the patient goes to a pharmacy, the pharmacist must check the Web
site to make sure that both doctor and patient have complied. The
pregnancy tests must have been taken within the previous seven days
and been performed by a certified laboratory. Another pregnancy test
will be required before the prescription is refilled.

"Ilena Rose" wrote in message
...


--------------------------------------------------------------------------------

August 13, 2005
F.D.A. Imposes Tougher Rules for Acne Drug

Excellent. The FDA is doing its job.

Jeff

copyrighted material deleted

"Jeff" wrote in message
nk.net...

"Ilena Rose" wrote in message
...


--------------------------------------------------------------------------------

August 13, 2005
F.D.A. Imposes Tougher Rules for Acne Drug

Excellent. The FDA is doing its job.

Jeff

And exposing the evils of the drug companies.

August 13, 2005
F.D.A. Imposes Tougher Rules for Acne Drug
By GARDINER HARRIS
WASHINGTON, Aug. 12 - The Food and Drug Administration announced tough
new regulations Friday for use of the acne drug Accutane. Officials of
the agency said they hoped that the rules would reduce the hundreds of
miscarriages, birth defects and abortions associated with the drug
each year.

The regulations, which apply to generic versions of Accutane as well,
require doctors and patients to register in an electronic database
before it can be dispensed. Female patients of childbearing age must
take two pregnancy tests and use two forms of birth control to get the
drug. And doctors and pharmacists must confirm that the requirements
have been met.

The new program is the latest and by far most drastic of more than 40
efforts by the agency in the last 22 years to reduce harm from
Accutane, an oral medicine made by Roche Holding, while allowing its
continued use.

Dr. Nancy Green, medical director for the March of Dimes, cheered the
announcement.

"If this doesn't work," Dr. Green said, "we will call for the F.D.A.
to take this drug off the market."

A Roche spokeswoman, Shelley Rosenstock, said the company also
welcomed the rules.

"Roche continues to support, to the extent possible, efforts to reduce
fetal exposures" to Accutane, Ms. Rosentstock said.

Health officials say the new plan is the latest sign the F.D.A. is
losing faith that the nation's doctors and pharmacists can adequately
safeguard the health of patients. Before 1998, the agency largely
confined itself to advising physicians and pharmacists about how to
prescribe and dispense safely any drugs with potentially dangerous
adverse effects, and trusted that its advice would be followed. But
experts say that time after time over the last decade, medical
professionals have ignored the advice, providing drugs to patients at
risk of severe complications.

In some cases, the agency has asked that a drug be withdrawn because
physicians and pharmacists proved unwilling to control its use. But
such withdrawals have left stranded thousands of patients who contend
that they needed those drugs to lead normal lives.

So instead, the agency has begun fashioning restricted distribution
programs, like the one it announced on Friday, to ensure that health
professionals follow its guidelines. Among the first was a program
created in 1998 to ensure that thalidomide, infamous for causing
thousands of birth defects in European babies during the 1960's, could
be safely used as a leprosy drug. More such programs have followed,
including one for the abortion drug Mifeprex.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,
a consumer advocacy organization, said the F.D.A. was recognizing that
patients needed protection from irresponsible physicians and
pharmacists. Dr. Wolfe added that drug companies were largely to
blame, though, saying their huge marketing efforts often encouraged
doctors to prescribe drugs excessively.

But Dr. Mark Naylor, an Oklahoma dermatologist, said with regret that
many doctors would stop prescribing Accutane because of the F.D.A.'s
new restrictions. While it is unfortunate that some doctors may have
failed to follow earlier, voluntary guidelines on Accutane, Dr. Naylor
said, "it's up to physicians and patients to decide how the drug gets
used, not the F.D.A."

The drug agency approved Accutane in 1982 for patients suffering from
severe, disfiguring acne. There are about 6,000 patients with this
severe condition in the United States, most of them men. For such
patients, the drug has provided a nearly miraculous cure. By 2002, the
last year before generic versions of the medicine entered the market,
sales of Accutane in the United States had risen to $380 million, with
doctors writing 170,000 prescriptions a month, half of which went to
women.

Although animal studies had suggested that Accutane caused birth
defects, the drug agency initially imposed few restrictions on its
sale. When the first reported birth defect occurred in 1983, the
agency responded by requiring pharmacists to affix red warning
stickers to every bottle of Accutane describing its effects on
fetuses. More than 40 label or other regulatory changes followed, but
birth defects only increased. The drug, reports suggest, may also
cause some patients to become suicidal.

In 2001, Roche and the F.D.A. announced a plan to cut fetal exposures
of Accutane to zero. Patients were asked to sign a consent form
describing Accutane's risks. Doctors were asked to affix yellow
stickers to their prescriptions to verify that female patients capable
of bearing children had undergone two pregnancy tests and promised to
use two forms of birth control.

But the system was entirely voluntary, and it did nothing to reduce
the number of pregnancies among women taking the drug. Some women
never got pregnancy tests or, in a few cases, had positive pregnancy
tests and still were given it. From 2001 to 2003, the agency received
reports of 325 pregnancies among women taking it, and agency officials
say such a number is probably only a fraction of the real total,
because most miscarriages and abortions are most likely not reported
to them.

In February 2004, an advisory committee recommended that many aspects
of the program to control Accutane's risks become mandatory. With its
announcement Friday, the F.D.A. has followed that advice. The new
plan, called iPledge, is expected to become fully operational by the
end of the year. The program will apply to men as well as to women, in
part because of the reports of Accutane's psychiatric effects but also
because it seeks to bar male patients' sharing the drug with women not
eligible to receive it.

Under the program, doctors who wish to prescribe Accutane or its
generic forms must first go to a Web site, list the patient's name in
the registry and, using an identification number for the patient,
confirm in the case of women that two pregnancy tests have been
performed. Patients, using the same identification code, must either
call an 800 number or visit a Web site to receive education about the
drug's risks, and women must confirm that they are taking two forms of
birth control.

When the patient goes to a pharmacy, the pharmacist must check the Web
site to make sure that both doctor and patient have complied. The
pregnancy tests must have been taken within the previous seven days
and been performed by a certified laboratory. Another pregnancy test
will be required before the prescription is refilled.

LadyLollipop wrote:
"Jeff" wrote in message
nk.net...

"Ilena Rose" wrote in message
...


--------------------------------------------------------------------------------

August 13, 2005
F.D.A. Imposes Tougher Rules for Acne Drug

Excellent. The FDA is doing its job.

Jeff

And exposing the evils of the drug companies.

August 13, 2005
F.D.A. Imposes Tougher Rules for Acne Drug
By GARDINER HARRIS
WASHINGTON, Aug. 12 - The Food and Drug Administration announced tough
new regulations Friday for use of the acne drug Accutane. Officials of
the agency said they hoped that the rules would reduce the hundreds of
miscarriages, birth defects and abortions associated with the drug
each year.

The regulations, which apply to generic versions of Accutane as well,
require doctors and patients to register in an electronic database
before it can be dispensed. Female patients of childbearing age must
take two pregnancy tests and use two forms of birth control to get the
drug. And doctors and pharmacists must confirm that the requirements
have been met.

The new program is the latest and by far most drastic of more than 40
efforts by the agency in the last 22 years to reduce harm from
Accutane, an oral medicine made by Roche Holding, while allowing its
continued use.

Dr. Nancy Green, medical director for the March of Dimes, cheered the
announcement.

"If this doesn't work," Dr. Green said, "we will call for the F.D.A.
to take this drug off the market."

A Roche spokeswoman, Shelley Rosenstock, said the company also
welcomed the rules.

"Roche continues to support, to the extent possible, efforts to reduce
fetal exposures" to Accutane, Ms. Rosentstock said.

Health officials say the new plan is the latest sign the F.D.A. is
losing faith that the nation's doctors and pharmacists can adequately
safeguard the health of patients. Before 1998, the agency largely
confined itself to advising physicians and pharmacists about how to
prescribe and dispense safely any drugs with potentially dangerous
adverse effects, and trusted that its advice would be followed. But
experts say that time after time over the last decade, medical
professionals have ignored the advice, providing drugs to patients at
risk of severe complications.

In some cases, the agency has asked that a drug be withdrawn because
physicians and pharmacists proved unwilling to control its use. But
such withdrawals have left stranded thousands of patients who contend
that they needed those drugs to lead normal lives.

So instead, the agency has begun fashioning restricted distribution
programs, like the one it announced on Friday, to ensure that health
professionals follow its guidelines. Among the first was a program
created in 1998 to ensure that thalidomide, infamous for causing
thousands of birth defects in European babies during the 1960's, could
be safely used as a leprosy drug. More such programs have followed,
including one for the abortion drug Mifeprex.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,
a consumer advocacy organization, said the F.D.A. was recognizing that
patients needed protection from irresponsible physicians and
pharmacists. Dr. Wolfe added that drug companies were largely to
blame, though, saying their huge marketing efforts often encouraged
doctors to prescribe drugs excessively.

But Dr. Mark Naylor, an Oklahoma dermatologist, said with regret that
many doctors would stop prescribing Accutane because of the F.D.A.'s
new restrictions. While it is unfortunate that some doctors may have
failed to follow earlier, voluntary guidelines on Accutane, Dr. Naylor
said, "it's up to physicians and patients to decide how the drug gets
used, not the F.D.A."

The drug agency approved Accutane in 1982 for patients suffering from
severe, disfiguring acne. There are about 6,000 patients with this
severe condition in the United States, most of them men. For such
patients, the drug has provided a nearly miraculous cure. By 2002, the
last year before generic versions of the medicine entered the market,
sales of Accutane in the United States had risen to $380 million, with
doctors writing 170,000 prescriptions a month, half of which went to
women.

Although animal studies had suggested that Accutane caused birth
defects, the drug agency initially imposed few restrictions on its
sale. When the first reported birth defect occurred in 1983, the
agency responded by requiring pharmacists to affix red warning
stickers to every bottle of Accutane describing its effects on
fetuses. More than 40 label or other regulatory changes followed, but
birth defects only increased. The drug, reports suggest, may also
cause some patients to become suicidal.

In 2001, Roche and the F.D.A. announced a plan to cut fetal exposures
of Accutane to zero. Patients were asked to sign a consent form
describing Accutane's risks. Doctors were asked to affix yellow
stickers to their prescriptions to verify that female patients capable
of bearing children had undergone two pregnancy tests and promised to
use two forms of birth control.

But the system was entirely voluntary, and it did nothing to reduce
the number of pregnancies among women taking the drug. Some women
never got pregnancy tests or, in a few cases, had positive pregnancy
tests and still were given it. From 2001 to 2003, the agency received
reports of 325 pregnancies among women taking it, and agency officials
say such a number is probably only a fraction of the real total,
because most miscarriages and abortions are most likely not reported
to them.

In February 2004, an advisory committee recommended that many aspects
of the program to control Accutane's risks become mandatory. With its
announcement Friday, the F.D.A. has followed that advice. The new
plan, called iPledge, is expected to become fully operational by the
end of the year. The program will apply to men as well as to women, in
part because of the reports of Accutane's psychiatric effects but also
because it seeks to bar male patients' sharing the drug with women not
eligible to receive it.

Under the program, doctors who wish to prescribe Accutane or its
generic forms must first go to a Web site, list the patient's name in
the registry and, using an identification number for the patient,
confirm in the case of women that two pregnancy tests have been
performed. Patients, using the same identification code, must either
call an 800 number or visit a Web site to receive education about the
drug's risks, and women must confirm that they are taking two forms of
birth control.

When the patient goes to a pharmacy, the pharmacist must check the Web
site to make sure that both doctor and patient have complied. The
pregnancy tests must have been taken within the previous seven days
and been performed by a certified laboratory. Another pregnancy test
will be required before the prescription is refilled.